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Opiniones y comentarios de aprendices correspondientes a Desarrollo farmacéutico por parte de Universidad de California en San Diego

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The University of California San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences Drug Development course brings you lectures from both faculty and industry experts. With this course, recorded on campus at UCSD, we seek to share our access to top people in the field who bring an unprecedented range of expertise on drug development. In this course you will learn the different stages of clinical development as well as the regulatory including but not limited to, an Investigational New Drug Application (IND), New Drug Application (NDA), and product labeling. Additionally you will learn how to Incorporate study design methods for consideration in the design of clinical protocols to assess safety, tolerability, and efficacy in multiple therapeutic areas. In this course you will learn the different phases of clinical development: * Phase 1 or early stage clinical trial are conducted primar­ily to determine how the new drug works in humans, its safety profile and to predict its dosage range. It typically involves between 30 and 100 healthy volunteers. * Phase 2 or Proof of Concept POC studies test for efficacy as well as safety and side effects in a group of between 30 to 200 hundred patients with the disease for which the new drug is being developed. * Phase 3 or late stage clinical development involve much larger group of patients, between a few hundred to thousands, depending on the indication, which will help determine if the new drug can be considered both safe and effective. It will involve control groups using placebo and/or current treatment as a comparison. * Product registration and approval process after a drug is considered safe and effective from Phase 3 trials, it must be authorized in each individual country before it can be marketed. All data gen­erated about the small molecule or biologic is collected and submitted to the regulatory authorities in the US at the FDA, Food and Drug Administration FDA, in Europe the EMA or European Medicines Agency, Japan Ministry of Health and other countries which may require their own national approvals. This course is intended as part 2 of a series: Drug Discovery (https://www.coursera.org/learn/drug-discovery), Drug Development and Drug Commercialization (https://www.coursera.org/learn/drug-commercialization). We would highly recommend that you take the courses in order since it will give you a better understanding on how a drug is discovered in the lab before being tested in clinical trials and then launched in the market place....

Principales reseñas

HG
15 de oct. de 2018

Very well done and informative. I truly appreciate the Drug process in entirety being broken down into sections that are easy to comprehend. It is obvious the speakers were chosen for their knowledge.

KR
24 de may. de 2020

I am really glad to have course offered by california university . Its really helpful for me. And i am thankful to all lecturer, and teachers to explain overall drug development process.\n\nThank you!

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176 - 200 de 339 revisiones para Desarrollo farmacéutico

por RANTHU A

2 de jul. de 2020

giving more information

por Israel V V

22 de jun. de 2020

I learned a lot, thanks

por Chintan B

26 de ago. de 2019

Very Informative course

por Pratik P

22 de abr. de 2020

Nc course it's useful

por RHIANE A C

1 de oct. de 2020

Knowledgeable course

por Akilesh

13 de jun. de 2020

Very useful course

por Magdoline N N

9 de oct. de 2019

Very useful course

por Sarah s

19 de nov. de 2020

Veryy nice course

por Melody F

19 de jul. de 2020

Excellent course!

por J P V

26 de may. de 2020

nice course .....

por aula s

6 de ene. de 2020

Thank you so much

por Sanchit V

17 de may. de 2020

excellent course

por Yuvashini E

10 de ene. de 2020

was very helpful

por Gozde I A

2 de sep. de 2019

Very informative

por SAMEER A

25 de jul. de 2018

EXCELLENT COURSE

por Anthony E J T

26 de jul. de 2020

Muy informativo

por julio r l

5 de may. de 2020

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por Shikha K

7 de jun. de 2020

great learning

por Leah F

9 de abr. de 2020

so interesting

por MEHEDI H R 2

29 de ago. de 2020

Great course.

por S.Nandha k

12 de jun. de 2020

Useful course

por Jonathan M

1 de dic. de 2020

Excellent!!!

por MRS. S

25 de ago. de 2020

Very helpful

por Rafael V

12 de jul. de 2020

Great Course

por parikshith s d

31 de ago. de 2020

magnifisant